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The Effect of Breastfeeding Support System

Primary Purpose

Preterm, Breastfeeding, Breast Milk

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Routine nursing care
breastfeeding support system
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm

Eligibility Criteria

30 Months - 34 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For the baby Gestation week between 30 weeks and 34 weeks, Birth weight of 1000 g and above, Spontaneous respiration, His vital signs are stable, Born with a 5-minute APGAR of 7 and above, Gavage-fed exclusively with breast and/or formula milk and ready to be switched to oral feeding, Grade III and IV intracranial hemorrhage and no periventricular locomosis, No known congenital diseases, Severe asphyxia, without chronic lung disease, Babies who did not develop NEC were included in the study. For mothers Over 18 years of age, literate, able to speak Turkish, Mothers who were willing to breastfeed and did not have a chronic disease that prevented breastfeeding were included in the study. Exclusion Criteria: Unidentified babies, Infants with unstable vital signs, Mothers with an obstacle to breastfeeding were excluded.

Sites / Locations

  • Sümeyye EKİCİ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breastfeeding Support System

Control group

Arm Description

The intervention group was given breastfeeding support system care

Routine nursing care was given to the pretrms in this groups without any breastfeeding support system care

Outcomes

Primary Outcome Measures

Mother-Infant Attachment Scale
The Turkish validity and reliability of this scale developed by Taylor et al. in 2005 was conducted by Aydemir Karakulak and Alparslan (2016). It is a scale that allows the mother to express her feelings towards her baby with a single word. This scale, which can be applied from the first day after birth, can be easily and quickly applied by the mother. The scale has 8 items and four Likert-type items. A score between 0 and 24 can be obtained from the scale. An increase in the score indicates that there is an attachment problem between the mother and the infant. Cronbach Alpha internal consistency coefficients of the scale were found to be 0.69 in the first stage and 0.68 in the second stage

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
August 15, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT06003959
Brief Title
The Effect of Breastfeeding Support System
Official Title
The Effect of Breastfeeding Support System on Breast Milk Quantity and Mother-Infant Bonding in Preterm Infants: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was conducted to investigate the effect of a breastfeeding support system on breast milk quantity and mother-infant attachment in preterm infants. This randomized controlled experimental study was conducted in the Level III Neonatal Intensive Care Unit (NICU) of a hospital in eastern Turkey between January and June 2022. The population of the study consisted of preterm infants and their mothers who received treatment and care in the NICU between the dates of the study. The study sample consisted of 70 preterm infants (35 experimental, 35 control) and their mothers who met the research criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Breastfeeding, Breast Milk, Breastfeeding Support System

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breastfeeding Support System
Arm Type
Experimental
Arm Description
The intervention group was given breastfeeding support system care
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine nursing care was given to the pretrms in this groups without any breastfeeding support system care
Intervention Type
Other
Intervention Name(s)
Routine nursing care
Intervention Description
Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic. Body weights of the babies were measured and recorded in the morning before the first feeding. The amount of breast milk to be given for feeding according to the clinic protocol was determined by the physician and the babies were fed with a bottle. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale before and after the feeding of their infants. These interventions were continued until the baby was fully breastfed.
Intervention Type
Other
Intervention Name(s)
breastfeeding support system
Intervention Description
Body weight of preterm infants in the experimental group was measured and recorded in the morning before the first feeding. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale in the pre-procedure period. The amount of breast milk that the preterm infant should receive during feeding was determined by the physician. Before feeding, the neonatal nurse ensured sterile preparation of the milk and transferred it to the Breastfeeding Support System. The mothers were then prepared for the procedure. Accordingly, the breastfeeding support system was explained to the mother by the specialized neonatal nurse. When the preparation of the mother and baby was completed, the baby was placed on the mother's breast. After feeding, the mother was asked to fill out the Mother-Infant Attachment Scale the again. These interventions were continued until the baby was fully transferred to the mother's breast.
Primary Outcome Measure Information:
Title
Mother-Infant Attachment Scale
Description
The Turkish validity and reliability of this scale developed by Taylor et al. in 2005 was conducted by Aydemir Karakulak and Alparslan (2016). It is a scale that allows the mother to express her feelings towards her baby with a single word. This scale, which can be applied from the first day after birth, can be easily and quickly applied by the mother. The scale has 8 items and four Likert-type items. A score between 0 and 24 can be obtained from the scale. An increase in the score indicates that there is an attachment problem between the mother and the infant. Cronbach Alpha internal consistency coefficients of the scale were found to be 0.69 in the first stage and 0.68 in the second stage
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
34 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For the baby Gestation week between 30 weeks and 34 weeks, Birth weight of 1000 g and above, Spontaneous respiration, His vital signs are stable, Born with a 5-minute APGAR of 7 and above, Gavage-fed exclusively with breast and/or formula milk and ready to be switched to oral feeding, Grade III and IV intracranial hemorrhage and no periventricular locomosis, No known congenital diseases, Severe asphyxia, without chronic lung disease, Babies who did not develop NEC were included in the study. For mothers Over 18 years of age, literate, able to speak Turkish, Mothers who were willing to breastfeed and did not have a chronic disease that prevented breastfeeding were included in the study. Exclusion Criteria: Unidentified babies, Infants with unstable vital signs, Mothers with an obstacle to breastfeeding were excluded.
Facility Information:
Facility Name
Sümeyye EKİCİ
City
Erzurum
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Breastfeeding Support System

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